Quality Engineer II - Instrument Plant
BD
Unknown, Maryland
Full-Time
$75,800
RemoteExecutive
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
As our Quality Engineer II, you'll be the go-to expert for applying and interpreting plant and department procedures, ensuring we stay consistent and compliant with our Quality Systems. You'll leverage sophisticated statistical and analytical tools while working across enterprise systems and corporate directives to support both new and existing product lines.
Responsibilities:
Champion Quality Compliance: Maintain International Organization for Standardization (ISO) and regional regulatory requirements across the entire product lifecycle - from design and manufacturing to assembly, testing, inspections, and customer complaint resolution
Master Documentation: Develop and maintain Device History Files in full compliance with regulatory requirements, ensuring every detail is captured and accessible
Drive Quality Intelligence: Generate critical CTQ (Critical to Quality) indices and provide actionable recommendations and solutions to emerging issues for project teams, operations, and suppliers
Lead Product Integration: Support the seamless integration of new products into Manufacturing and Operations, ensuring quality is built in from day one
Ensure Regulatory Excellence: Guarantee that BD Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet all applicable regulatory requirements
Mentor and Coach: Share your expertise by helping others understand and apply Quality Systems and procedures effectively
Analyze and Optimize: Perform sophisticated trend analysis, risk management (including FMEA, Hazard Analysis, and Fault Tree analysis), and apply Six Sigma tools to drive continuous improvement
Variety: Support one or more instrument platforms on sustaining activities including complaints, non-conformances, and daily operational challenges
Leadership Opportunities: Take the lead on root cause investigations for moderately complex issues and make a tangible difference
Cross-Functional Collaboration: Work closely with Research and Development, Operations, and other key departments - collaboration is part of your daily routine!
Hands-On Problem Solving: Actively participate on teams, support audits, ensure documentation compliance, and process CAPAs, change controls, and deviation waivers
Strategic Impact: Your work directly influences product quality and customer satisfaction across our entire portfolio
Education and Experience:
Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs.
2+ years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
Experience in a medical device or pharmaceutical manufacturing facility.
SAP transaction experience.
Knowledge and Skills:
Multi-task management and change management plan execution
Conflict management and results-driven performance with minimal supervision
Team collaboration and cross-functional coordination
FDA 21 CFR 820 regulations (moderate knowledge, ISO 9000:2000 and ISO 13485:2003 standards (moderate knowledge), GLP/GMP/ISO requirements and Quality System regulations
Medical device regulations and regulated environment experience
Design Control requirements
Medical Device Validations (preferred)
Data analysis using Six Sigma, root cause analysis, failure analysis, and risk assessment (moderate to difficult complexity)
Statistical methods and tools application
Risk management and risk-based decision making
Proficiency in Excel, PowerPoint, and statistical software packages
Word processing and spreadsheet expertise
First-hand audit experience (Preferred)
Microbiology/molecular science background (Preferred)
Data efficiency optimization (Preferred)
Preferred Qualifications:
Manual assembly manufacturing experience
Microbiological and chemical test methods
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
.
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$75,800.00 - $121,300.00 USD Annual